STATIM DIAGNOSTICS LIMITED

Statim Diagnostics Limited, trading as Statim Ltd, is a Dublin‑based specialist offering regulatory and scientific advisory services to pharmaceutical and biotechnology companies. With a clear focus on European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) frameworks, Statim helps clients navigate the intricate requirements of drug registration, ensuring that products meet the highest standards of safety and efficacy before reaching the market.

The firm’s portfolio covers a comprehensive suite of services, including expert EMA and MHRA regulatory guidance, full‑scale drug registration across EMA member states, and the preparation of critical documentation such as protocols, Investigator’s Brochures, IMPDs and Informed Consent Forms. In addition, Statim assists clients in securing marketing authorisation, providing a seamless route from development to commercialisation.

By combining deep regulatory knowledge with a pragmatic, client‑centred approach, Statim Diagnostics Limited enables pharma and biotech organisations to achieve compliance confidence, accelerate approvals and successfully launch their innovations throughout Europe.